Lessons from Early Deployments in The Netherlands
Lawrenceville, NJ, USA—July 15, 2019—Value in
Health, the
official journal of ISPOR—the
professional society for health economics and outcomes research, announced today the
publication of new research from The Netherlands showing important gaps in the deployment
of “coverage with evidence development,” a type of pharmaceutical managed entry
agreement that gives patients access to treatments while additional evidence is
being collected. The report, “Uncertainty
and Coverage With Evidence Development: Does Practice Meet Theory?” was published in the July
2019 issue of Value in Health.
Reimbursement decisions
concerning pharmaceuticals are subject to uncertainty. Over the years, decision
makers have employed a variety of policy measures, called managed entry agreements,
to regulate the reimbursement of new, often expensive, healthcare innovations. “Coverage
with evidence development” (CED) is one type of managed entry agreement that
aims to reduce the uncertainty surrounding the (cost) effectiveness of
treatments by granting access to these treatments to patients while additional
evidence is being collected.
The Dutch have been
leaders in implementing managed entry agreements of various types, including
CED. In The Netherlands, CED has been used to regulate the reimbursement of expensive
medicines since 2006 and of specific outpatient pharmaceuticals since 2012.
Despite the widespread use of CED, evaluation of the value of specific CED arrangements
has been lacking.
In order to determine whether
the practical implementation of CED in The Netherlands has included all the crucial
steps for successful implementation, the authors examined the first 3 CED
schemes that were completed in The Netherlands. The initial and final
assessment dossiers for these cases have been published on the Dutch Health Care
Institute (Zorginstituut Nederland) website:
- Alglucosidase Alfa (Myozyme®) for the treatment of Pompe's
disease
- Rituximab (MabThera®) for the treatment of rheumatoid arthritis
- Trastuzumab (Herceptin®) for the treatment of human epidermal
growth factor receptor 2 positive early breast cancer
The findings were
disappointing. Unfortunately, in these 3 CED implementations, uncertainties
were neither systematically nor completely identified. Furthermore, the
analyzed dossiers did not justify why specific outcomes were not included in
the CED research plan.
“These findings support the
need for a more systematic approach to identify uncertainties in assessments
and to explore the impact of these uncertainties on the results and decision
making,” said author Xavier G.L.V. Pouwels, MSc, Department of Clinical
Epidemiology and Medical Technology Assessment, Maastricht University Medical
Centre+, Maastricht, The Netherlands. “Such an approach should rest on a clear
definition of uncertainty and its sources. A framework would help to
systematically identify uncertainty, and this process should involve all
stakeholders. Value of information analysis, and the uncertainties that are not
included in this analysis, should inform CED research design.”
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ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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ABOUT VALUE IN HEALTH
Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2018 impact factor score is 5.037. Value in Health is ranked 4th among 81 journals in health policy and services, 5th among 98 journals in healthcare sciences and services, and 11th among 363 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
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